A Study of Abatacept in Patients With Active Ulcerative Colitis

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: abatacept (ABA)

Drug: abatacept

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00410410

IM101-108

Details and patient eligibility

About

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

Full description

The Induction Period First Cohort (IP1C) arms (30/10 mg/kg and 10 mg/kg) were placebo-controlled arms that were used for the primary endpoint and its analysis. The Induction Period Second Cohort arms (IP2C 30/10 mg/kg and 10 mg/kg) were not placebo-controlled, their sole purpose being to provide sufficient numbers of participants for the maintenance phase. The first cohort (IP1C) was randomized to receive placebo or 1 of 3 doses of abatacept. Following completion of the IP1C randomization, a second cohort (IP2C) was randomized to receive 1 of 2 doses of abatacept. After all participants in the IP1C completed or discontinued, the data was locked and the formal analysis for the Induction Period primary endpoint was performed. Summary tables for the second cohort (IP2C) and the Maintenance and Open-label phases were generated from a second, subsequent data lock.

Enrollment

591 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Men or women 18 years or older
Ulcerative colitis for at lease 3 months
Moderate to severe active ulcerative colitis
Inadequate response or intolerance to standard ulcerative colitis treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

591 participants in 3 patient groups, including a placebo group

Abatacept (ABA)

Experimental group

Description:

Induction Period; 3 arms for Cohort 1: ABA 30/\~10 mg/kg (ABA administered at 30 mg/kg followed by ABA at \~10 mg/kg), ABA \~10 mg/kg, ABA 3 mg/kg Induction Period; 2 arms for Cohort 2: ABA 30/\~10 mg/kg and Second Cohort ABA \~10 mg/kg 1 arm for maintenance period (ABA \~10 mg/kg)

Treatment:

Drug: abatacept (ABA)

Placebo

Placebo Comparator group

Description:

1 arm for induction period 1 arm for maintenance period

Treatment:

Drug: placebo

abatacept

Other group

Description:

1 arm for open-label extension phase (ABA \~10 mg/kg)